Pharmaceutical preparation for the treatment of the symptoms of addiction and method of diagnosing same

ABSTRACT

A therapeutic agent for the treatment of the symptoms of addiction and the method for preparing the therapeutic agent is disclosed. The therapeutic agent is a stable pharmaceutical preparation containing, but not limited to, digestive/pancreatic enzymes. The therapeutic agent may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic agent may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using of a biomarker, the presence of chymotrypsin in the gastrointestinal tract to determine the presence of symptoms of addiction, and the likelihood of relapsing into addiction is disclosed.

RELATED APPLICATIONS

This application is a continuation of U.S. Utility patent applicationSer. No. 12/426,794, filed Apr. 20, 2009, now U.S. Pat. No. 8,084,025,which claims the benefit of U.S. Provisional Patent Application No.61/046,026, filed Apr. 18, 2008, each of which are incorporated byreference herein in their entirety.

TECHNICAL FIELD

The invention relates to a treatment for the symptoms of addiction, andmore particularly, to the use of digestive/pancreatic enzymes in thetreatment of the symptoms of drug and alcohol addiction. The inventionfurther relates to method of diagnosing the symptoms of addiction. Moreparticularly, the invention further relates to measuring fecalchymotrypsin levels to diagnose the symptoms of drug and alcoholaddiction and the possibility of relapse into drug and alcoholaddiction.

BACKGROUND OF THE DISCLOSURE

Addiction is a dependence on a behavior or substance that a person ispowerless to stop. The term has been partially replaced by the word“dependence” for substance abuse. Addiction has been extended, however,to include mood-altering behaviors or activities. Some researchers speakof two types of addictions: substance addictions (for example,alcoholism, drug abuse, and smoking); and process addictions (forexample, gambling, spending, shopping, eating, and sexual activity).There is a growing recognition that many addicts, such as polydrugabusers, are addicted to more than one sub-stance or process.

Addiction is one of the most costly public health problems in the UnitedStates. It is a progressive syndrome, which means that it increases inseverity over time unless it is treated. Substance abuse ischaracterized by frequent relapse, or return to the abused substance.Substance abusers often make repeated attempts to quit before they aresuccessful.

In 1995 the economic cost of substance abuse in the United Statesexceeded $414 billion, with health care costs attributed to substanceabuse estimated at more than $114 billion.

By eighth grade, 52% of adolescents have consumed alcohol, 41% havesmoked tobacco, and 20% have smoked marijuana. Compared to females,males are almost four times as likely to be heavy drinkers, nearly oneand a half more likely to smoke a pack or more of cigarettes daily, andtwice as likely to smoke marijuana weekly. However, among adolescentsthese gender differences are decreasing. Although frequent use oftobacco, cocaine and heavy drinking appears to have remained stable inthe 1990s, marijuana use increased.

In 1999, an estimated four million Americans over the age of 12 usedprescription pain relievers, sedatives, and stimulants for “nonmedical”reasons during one month.

In the United States, 25% of the population regularly uses tobacco.Tobacco use reportedly kills 2 5 times as many people each year asalcohol and drug abuse combined. According to 1998 data from the WorldHealth Organization, there were 1.1 billion smokers worldwide and 10,000tobacco-related deaths per day. Furthermore, in the United States, 43%of children aged 2 to 11 years are exposed to environmental tobaccosmoke, which has been implicated in sudden infant death syndrome, lowbirth weight, asthma, middle ear disease, pneumonia, cough, and upperrespiratory infection.

Individuals going through alcohol rehabilitation or breaking drugaddiction know the pain that chemicals can cause. All recoveringalcoholics and drug users understand the toll that drug abuses take onthe body, mind and emotions. Alcohol and drugs cause tremendous nutrientdeficiencies as well as a need for very specific nutrients that are onlyfound within nature's foods. These nutrients:

-   -   Support the liver    -   Help the body detoxify    -   Produce energy    -   Rebuild vitamin and mineral levels    -   Feed the brain and emotions    -   Support the blood vessels    -   Feed the nervous system    -   Balance blood sugar

One of the most obvious signs of drug and alcohol abuse is the depletionof the vitamin B complex. The challenge of addiction recovery can bemade more difficult when coupled with nutritional deficiencies. Thechronic depletion of vitamin B complex, for example, can lead to adrenaldepletion as well. Since vitamin B complex provides cellular energy,nervous transmission, muscle health (contraction and relaxation), hearthealth, blood sugar metabolism, normal weight control, cellular regrowthand many functions related to emotional stability and thinkingprocesses, this vitamin complex is absolutely necessary forreplenishment. But vitamin B complex should only come from food, notfrom isolated or groups of vitamin pills. Similarly, the depletion ofminerals such as calcium is very serious. Other important mineralsinclude selenium, phosphorus, sulfur, zinc, potassium, and magnesium,which are all found in nature's raw vegetables.

Of course, the liver is one of the most injured organs in cases ofalcoholism and drug abuse. The reason is because the liver is part ofthe digestive system and is used by the body to filter out and storetoxins. When it is overtaxed, the liver can become fatty or damaged orboth. It is critical that those going through drug or alcoholrehabilitation emphasize liver healing.

Alcohol blocks the absorption and breakdown of nutrients by damaging thecells lining the stomach and intestines, and by decreasing the amount ofdigestive enzymes secreted by the pancreas. For reasons that aren't yetknown, the pancreas can become inflamed and leak digestive enzymes,which then attack the pancreas itself. Pancreatitis is extremely painfuland can be fatal.

In view of such findings, there is need for a method of treating thoseexhibiting symptoms of drug and alcohol addiction.

No description in the Background section should be taken as an admissionthat such disclosure constitutes prior art to the instant invention.

SUMMARY OF THE DISCLOSURE

The present invention is directed to the use of therapeutic agents inthe treatment of the symptoms of drug and alcohol addiction and themethod of preparing those agents. Further, the invention is directed toa method of diagnosing the symptoms of addiction and the possibility ofrelapse into drug and alcohol addiction.

More specifically, the present invention relates to stablepharmaceutical preparations containing, but not limited to,digestive/pancreatic enzymes, including, but not limited to, amylases,proteases, cellulase, papaya, papain, bromelain, lipases, chymotrypsinand hydrolases. This combination is made by, but not limited to: directcompression, microencapsulation, lipid encapsulation, wet granulation orother methods including the use of Prosolv®, microencapsulation, lipidencapsulation technology, or other suitable technology. This technologycan include the use of rapid dissolution (rapid dissolve), time releaseor other delivery methods including oral, injection, patch or othermethod. Further, the delivery of the enzymes can be in the form of atablet, sprinkles, sachet, capsules, caplets or other compressed tabletdelivery, or other oral delivery method.

Further, the invention is directed toward the use of a biomarker, thepresence of chymotrypsin in the GI tract to determine a lack of proteindigestion, nutrient absorption, and other related symptoms of drug andalcohol addiction.

It is a goal of the present invention to provide therapeutic agents forthe treatment of the symptoms of drug and alcohol addiction and providea method for preparing those agents.

Another goal of the present invention is to formulate stablepharmaceutical preparations containing, but not limited to,digestive/pancreatic enzymes including, but not limited to, amylases,proteases, cellulase, papaya, papain, bromelain, lipases, chymotrypsin;and hydrolases.

Yet another goal of the present invention is to make a combination ofdigestive/pancreatic enzymes utilizing, by but not limited to: directcompression, microencapsulation, lipid encapsulation, wet granulation orother methods including the use of Prosolv®, and other known excipientsand additives to accomplish microencapsulation, lipid encapsulation,direct compression, wet or dry granulation or other suitable technology.

A further goal of the present invention is to deliver the preparation bymeans, which can include the use of rapid dissolution (rapid dissolve),time release, or other delivery methods including oral, injection,patch, or other method. Further, the delivery of the enzymes may be inthe form of a tablet, capsule, sprinkles, sachet, or other oral deliverymethod.

An additional goal of the invention is to demonstrate the use of fecalchymotrypsin as a prognosticative indicator of the presence of thesymptoms of drug and alcohol addiction, or the likelihood of anindividual to relapse into drug and alcohol addiction.

The features and advantages described herein are not all-inclusive and,in particular, many additional features and advantages will be apparentto one of ordinary skill in the art in view of the drawings,specification, and claims. Moreover, it should be noted that thelanguage used in the specification has been principally selected forreadability and instructional purposes, and not to limit the scope ofthe inventive subject matter.

DETAILED DESCRIPTION

The individual who is diagnosed as alcoholic or as substance abuseaddicted is administered a fecal chymotryspin test where the level ofthe enzyme chymotrypsin is measured. The individual is then given aneffective amount of pancreatic/digestive enzymes if the fecalchymotryspin level is below 8.4 U/gram. This level is consideredabnormal when compared to an individual without alcoholism or substanceabuse addiction, or who is not at risk for such an addiction, or havingbeen addicted at any time in the past, or who has other proteindigestion problems.

The fecal chymotrypsin levels may be measured in someone at risk forbecoming an alcoholic or substance abuse addicted or who has had ahistory of alcoholism or substance abuse and who may again become analcoholic or substance abuse addicted. The steps involve the following:taking a stool sample from the individual to be diagnosed, measuring thelevel of fecal chymotrypsin in the stool sample, and comparing thatlevel to an individual who does not have alcoholism, a substance abuseproblem or other protein digestion problem. When the level is low, lessthan 8.4 U/gram, an effective amount of pancreatic enzymes isadministered to the individual.

The invention may be used as the or one of the components of an alcoholtreatment or substance abuse treatment program for an active alcoholicor substance abuse addict. The invention may also be utilized to keepsomeone at risk for becoming an alcoholic or substance abuser or it maybe used to prevent someone from relapse into addiction. Thepancreatic/digestive enzymes may be given to prevent addiction, such asalcoholism or substance abuse, to help someone who is presently anaddict such as an alcoholic or drug addict, or to someone who is at riskof relapse. The enzymes may be administered as a result of a loweredfecal chymotrypsin level.

Pancreatic/digestive enzymes may be administered to those who arepresently battling active addiction such as alcoholism or drug abuse.They may be given to those who are not actively addicted, but who havebeen addicted at another time and who are at risk for becoming anaddict, such as an alcoholic, drug addict or other substance abuseaddict. They may also be utilized for those who are deemed at risk foraddiction, such as alcoholism, due to family history or other historicalevents, such as severe stress or other factors placing the individual atrisk.

In one embodiment, a stable preparation of digestive/pancreatic enzymesis formed into a dosage formulation containing a therapeuticallyeffective amount of a protease, an amylase, and/or a lipase. Theformulation may include additional enzymes, such as pancreatin,chymotrypsin, trypsin, papain and/or papaya. Other combinations ofdigestive enzymes may also be used. These enzymes can be in the form ofanimal or plant derivatives, natural or synthetic.

The following outlines a formulary for digestive/pancreatic enzymes fortreating the symptoms of addiction:

-   Amylase 10,000-60,000 U.S.P-   Protease 10,000-70,000 U.S.P-   Lipase 4,000-30,000 U.S.P-   Pancreatin 2,000-6,000 U.S.P-   Chymotrypsin 2-5 mg-   Trypsin 60-100 mg-   Papain 3,000-10,000 USP units/mg-   Papaya 30-60 mg

The dosage formulation may be administered by an oral preparationincluding, but not limited to, an encapsulated tablet, mini-tabs,microcapsule, mini-capsule, time released capsule, sprinkle or othermethodology. In one embodiment, the oral preparation is encapsulatedusing Prosolv technology. Alternatively, the oral preparation may beencapsulated using enteric coating, lipid encapsulation, directcompression, dry granulation, wet granulation, and/or a combination ofthese methods.

Fecal chymotrypsin is a sensitive, specific measure of proteolyticactivity. Normal levels of chymotrypsin are considered be greater than8.4 U/gram. Decreased values (less than 8.4 U/gram) suggest diminishedpancreatic output (pancreatic insufficiency), hypoacidity of the stomachor cystic fibrosis. Elevated chymotrypsin values suggest rapid transittime, or less likely, a large output of chymotrypsin from the pancreas.

For the fecal chymotrypsin test, a stool sample is collected from eachof the subjects. Each stool sample is analyzed using an enzymatic photospectrometry analysis to determine the level of fecal chymotrypsin inthe stool. Alternatively, other methods, such as the colorimetricmethod, use of substrates, use of assays, and/or any other suitablemethod may be used to measure the fecal chymotrypsin levels. The levelsof fecal chymotrypsin in the samples of the individuals to be diagnosedare compared to the levels of fecal chymotrypsin in an individual whodoes not have alcoholism, a substance abuse problem or other proteindigestion problem to determine if the individual being diagnosed wouldbenefit from the administration of digestive enzymes.

The foregoing description of the embodiments of the invention has beenpresented for the purposes of illustration and description. It is notintended to be exhaustive or to limit the invention to the precise formdisclosed. Many modifications and variations are possible in light ofthis disclosure. It is intended that the scope of the invention belimited not by this detailed description, but rather by the claimsappended hereto.

1. A method for treating an alcohol or drug addicted individualexhibiting one or more symptoms of alcohol or drug addiction, whereinthe one or more symptoms comprise a lack of protein digestion, a lack ofnutrient absorption or a combination thereof; the method comprising: (a)obtaining a fecal sample from the individual; (b) measuring a level ofchymotrypsin present in the fecal sample, wherein measuring comprisesenzymatic photospectrometry analysis; (c) comparing the level ofchymotrypsin present in the fecal sample to a normal level of fecalchymotrypsin; (d) administering a therapeutically effective amount ofdigestive enzymes to the individual if the measured fecal level ofchymotrypsin is less than the normal level of fecal chymotrypsin;wherein the digestive enzymes comprise pancreatin, amylases, lipases,proteases or a combination thereof.
 2. The method of claim 1, whereinthe proteases comprise chymotrypsin, trypsin, papain or a combinationthereof.
 3. The method of claim 1, wherein the digestive enzymes areprepared using a technology comprising enteric coating, lipidencapsulation, direct compression, dry granulation, wet granulation or acombination thereof.
 4. The method of claim 1, wherein the digestiveenzymes are administered orally via a dosage formulation comprisingpills, tablets, capsules, microcapsules, mini-capsules, time releasedcapsules, mini-tabs, sprinkles, or a combination thereof.
 5. The methodof claim 1, wherein the amount of amylases ranges from 10,000 to 60,000USP units/dose.
 6. The method of claim 1, wherein the amount ofproteases ranges from 10,000 to 70,000 USP units/dose.
 7. The method ofclaim 1, wherein the amount of lipases ranges from 4,000 to 30,000 USPunits/dose.
 8. The method of claim 1, wherein the amount of pancreatinranges from 2,000 to 6,000 USP units/dose.
 9. The method of claim 2,wherein the amount of papain ranges from 3,000 to 10,000 USP units/dose.10. The method of claim 2, wherein the amount of trypsin ranges from 60to 100 mg.
 11. The method of claim 1, wherein one of the one or moresymptoms of the drug or alcohol addiction is ameliorated.
 12. The methodof claim 1, wherein the total amount of the digestive enzymes rangesfrom about 4,000 to about 176,000 USP units/dose.
 13. The method ofclaim 1, wherein the normal level is 8.4 U/gram.